New treatment for adults with mantle cell lymphoma approved

Mantle cell lymphoma is a rare and aggressive type of non-Hodgkin lymphoma that represents 3 to 10 percent of all non-Hodgkin lymphomas.
By Amy Wallace  |  Oct. 31, 2017 at 2:12 PM
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Oct. 31 (UPI) -- The U.S. Food and Drug Administration today approved a new treatment for adult patients with mantle cell lymphoma, an aggressive type of non-Hodgkin lymphoma.

The FDA granted accelerated approval of Calquence, or acalabrutinib, a kinase inhibitor that works by blocking an enzyme key to the cancer's ability to grow and spread.

Mantle cell lymphoma is a rare and aggressive form of non-Hodgkin lymphoma, a cancer of the lymph system, which includes lymph tissue, nodes, spleen, thymus, tonsils and bone marrow. Nearly 3 to 10 percent of all non-Hodgkin lymphomas in the United States are mantle cell lymphoma, according to the National Cancer Institute at the National Institutes of Health.

"Mantle cell lymphoma is a particularly aggressive cancer," Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a news release.

"For patients who have not responded to treatment or have relapsed, Calquence provides a new treatment option that has shown high rates of response for some patients in initial studies."

The approval of Calquence was based on data from a clinical trial of 124 patients with mantle cell lymphoma who received at least one prior treatment.

Researchers found that after treatment with Calquence, 81 percent of patients had a complete or partial tumor shrinkage -- 40 percent had a complete response and 41 percent had a partial response to the treatment.

"The acalabrutinib approval represents an important development for patients currently battling mantle cell lymphoma," Dr. Michael Wang, a professor at the University of Texas MD Anderson Cancer Center who led the clinical trial, said in a press release.

"In addition to the overall response rate, the high complete response rate of 40 percent seen in this trial illustrates the potential of acalabrutinib to help patients achieve a deep response," he said.

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